The FDA has approved the application to initiate a First-in-Human phase I clinical trial with BXQ-350 for the treatment of cancer.
This open-label trial will include adult patients with advanced solid tumors (including glioma). The trial is designed to determine the maximum tolerated dose of BXQ-350 and characterize its safety and pharmacokinetics.
In pre-clinical animal studies, BXQ-350 was shown to induce tumor cell death in a variety of cancers, while leaving healthy cells unharmed. BXQ-350 is a unique formulation of a synthetically produced, human lysosomal protein. BXQ-350 is a proprietary nanovesicle formulation comprised of Saposin C (sphingolipid activator protein) and the phospholipid dioleoylphosphatidylserine.